By: Ed Susman
VANCOUVER, BRITISH COLUMBIA, CANADA – Treatment of mild to moderate Alzheimer’s disease with intravenous immunoglobulin resulted in a slowing of progression of the disease over 3 years in a small population of patients, researchers said at the 2012 Alzheimer’s Association International Conference.
Remarkably, 4 of the 16 patients who completed 36 months of treatment experienced no change in 4 domains of treatment while treated with intravenous immunoglobulin 0.4 mg/kg every 2 weeks, said Norman Relkin, MD, Weill Cornell Medical School, New York, New York, at his poster presentation.
“That means these 4 people were as they were when they began treatment,” said Dr. Relkin during a press briefing. “They had a mild stage of the disease; they were forgetful, they had word-finding difficulty and difficulty in expressing things, but they are still pretty much able to function with a little reminding and a little help in a fairly normal way.”
Dr. Relkin reported the results of a phase 2 extension trial that originally included 24 patients with mild to moderate Alzheimer’s disease. The 16 patients who completed the trial included 11 patients who took various doses of intravenous immunoglobulin across the 36-month course of the trial, and 5 patients who began on placebo for 6 months and then were treated with intravenous immunoglobulin in the extended phase of the trial.
The 4 patients who did not progress were all initially randomised to IVIG 0.4g/kg/ every 2 weeks. They were unchanged from their pre-treatment baseline on measures of cognition, daily function, behaviour, global outcome, and caregiver burden after 3 years.
“This is the first study to provide evidence that intravenous immunoglobulin can benefit Alzheimer’s patients for as long as 36 months,” said Dr. Relkin. “Most Alzheimer patients decline measurably in 3 to 6 months if untreated and within 1 year of initiating currently available treatments. Patients who received intravenous immunoglobulin for a full 36 months in this study had less than expected decline.”
Overall, the rate of progression among these patients was about 50% of what was expected, he said. “However I would not make much of those statistics because of the small numbers of patients,” he said. “I emphasise the group that did not change over time.”
Dr. Relkin said that the treatment was generally well-tolerated. “Most of the adverse events that we saw in this trial are expected for intravenous immunoglobulin such as things like rashes, chills, and fever, which are typically short-lived,” he said.
Major side effects for intravenous immunoglobulin relate to it being a viscous solution that can increase risk of clotting.
“We excluded people from this study who had heart attacks or strokes to lower that risk but we still did see some vascular related events,” said Dr. Relkin.
“We have the advantage of 30 years of background on this drug and its safety profile is well known. There was 1 patient who experienced a transient ischemic attack. That person fully recovered but was removed from the trial.”
- MFP Wire Services